Trial document




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  DRKS00004862

Trial Description

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Title

Vibration and balance training in breast cancer patients during radiotherapy - pilot study

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Trial Acronym

ViBBRa-pilot

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URL of the Trial

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Brief Summary in Lay Language

Breast cancer patients often suffer from different side-effects of their disease and therapy (surgery/chemo-/radiotherapy). Besides lymphedema and/or limited range of motion of the affected arm/shoulder, many patients have balance problems and reduced physical fitness caused by chemotherapy resulting in a decrease of quality of life.
Previous studies already proved, that physical activity interventions have a positive effect to preserve both, the quality of life and physical capacity.
The aim of this study is to evaluate the feasibility of a hand-held-vibration training, a balance- and endurance training and the effects on lymphedema, range of motion of the shoulder, as well as postural control and endurance capacity. Therefore patients will be allocated either to a training group or a control group without intervention depending on their individual preference.
No statement can be made about the effectiveness of an hand-held vibration training in breast cancer patients, because it has not yet been examined so far.

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Brief Summary in Scientific Language

The aim of this pilot study is to evaulate the feasibility of a handheld vibration- and balance-training with breast cancer patients undergoing radiotherapy.
Breast cancer patients receiving radiotherapy (with or without lymphatic pathways) will be recruted and allocated either to an intervention group (IG) or a control group (CG) depending on their preference.
Study protocol provides an intervention period of approximately 6 weeks, 3 times per week, 1 hour per training session including handheld vibration-, balance- and endurance training on a bicycle ergometer. The CG recieves no intervention.
Pre- and post measurements will be performed before and after radiotherapy. Primary endpoint is the amount (%) of feasible training sessions of handheld vibration- and balance training during radiotherapy compared to state of the art. Further endpoints are postural control and mobility, range of motion of the shoulder, lympedema, max. manual force, endurance capacity, quality of life and fatigue.

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Organizational Data

  •   DRKS00004862
  •   2013/04/26
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  •   yes
  •   Approved
  •   478/11_130272, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Intervention for intervention group 3x/week over 6 weeks, 1 hour per training session: handheld vibration training with Galileo® UpX Dumbbell (3x5 exercises, 20min), balance training (3-6 exercises, 20min), endurance training on bicycle ergometer (60-75% of max. HR, 20min)
  •   control group: no intervention, pre and post measurements
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

performed exercise sessions of IG compared to state of the art [%] (feasibilty of handheld vibration and balance training during radiotherapy)

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Secondary Outcome

Secondary endpoint will be assessed pre and post intervention (before radiation therapy and after 6 weeks with termination of radiation therapy) Lymphedema (volume in cm3), postural control (sway path of center of force (COF) in cm), mobility (sec in chair-rising-test), endurance capacity (watt at individual anaerobic threshold (IAT)), quality of life (EORCT-QLQ-C30), fatigue (MFI)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/05/31
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- breast cancer patients undergoing adjuvant radiotherapy (with or without lymphatic pathways)
- Age ≥18 years
- Performance- Status Karnofsky- Index >60
- Signed informed consent

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Exclusion Criteria

Absolute:
- Instable bone metastases
- Myocardial infarction, Angina pectoris or heart disease (NYHA III-IV) in a time period of six months
- Arterial hypertension, which is not treated adequately (in therapy >180mmHg systolic; >100mmHg diastolic)
- Patients with an increased risk for thrombosis besides underlying disease

Relative (inclusion or continuation after recovery possible):
- Acute infection (≥38,0°Celcius and/ or intravenously therapy with antibiotics)
- Thrombocytes < 10x10^9/L
- Leukocytes < 1x10^9/L
- Hb < 8g/dl

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Addresses

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    • Medizinische Universitätsklinik Freiburg Abtl. Hämatologie/Onkologie
    • Mr.  Professor  Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Klinik für Strahlenheilkunde Radiologische Klinik Universitätsklinikum Freiburg
    • Ms.  Dr. med.  Natalja  Volegova-Neher 
    • Robert-Koch-Straße 3
    • 79106  Freiburg im Breisgau
    • Germany
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    • Universität Freiburg, Institut für Sport und Sportwissenschaft
    • Mr.  Professor  Albert  Gollhofer 
    • Schwarzwaldstr. 175
    • 79117  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Department Innere Medizin Institut für Bewegungs- und Arbeitsmedizin
    • Mr.  Prof. Dr.  Peter  Deibert 
    • Hugstetterstr. 55
    • 79106  Freiburg. i. Br.
    • Germany
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    • Medizinische Universitätsklinik Innere Medizin IKlinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Sarah  Kneis 
    • Hugstetter Str.55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Universitätsklinik Freiburg Klinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Sarah  Kneis 
    • Hugstetterstr.55
    • 79117  Freiburg
    • Germany
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    • Universitätsklinik Freiburg Klinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Ms.  Sarah  Kneis 
    • Hugstetterstr. 55
    • 79117  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Universitätsklinik, Klinik für Innere Medizin ISchwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.  Hartmut  Bertz 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

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